NCT00320346

Brief Summary

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

July 19, 2016

Status Verified

November 1, 2008

First QC Date

May 1, 2006

Last Update Submit

July 17, 2016

Conditions

Influenza

Keywords

PandemicInfluenzaPreventionVaccinePrevention of Pandemic Influenza

Outcome Measures

Primary Outcomes (1)

  • Safety and Immunogenicity

Secondary Outcomes (1)

  • Lot to Lot Consistency

Interventions

Pandemic Influenza VaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Adults

You may not qualify if:

  • Previous vaccination with an influenza Vaccine containing the H5N1 strain
  • History of clinically significant medical conditions
  • History of Guillian-Barre Syndrome or active Neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CMAX, a division of IDT Australia

Adelaide, South Australia, Australia

Location

Murdoch Childrens Research Institute

Melbourne, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Location

Related Publications (1)

  • Nolan TM, Richmond PC, Skeljo MV, Pearce G, Hartel G, Formica NT, Hoschler K, Bennet J, Ryan D, Papanaoum K, Basser RL, Zambon MC. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine. 2008 Aug 5;26(33):4160-7. doi: 10.1016/j.vaccine.2008.05.077. Epub 2008 Jun 13.

    PMID: 18599164DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Peter Richmond, Dr

    Princess Margaret Hospital for Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

July 1, 2006

Study Completion

September 1, 2006

Last Updated

July 19, 2016

Record last verified: 2008-11

Locations

AU(3)